Exploring the Effectiveness and Safety of Amino Acid Peritoneal Dialysis Solution

Exploring the Effectiveness and Safety of Amino Acid Peritoneal Dialysis Solution in Improving Nutritional Status in Maintenance Peritoneal Dialysis Patients: a Multicenter, Open, Prospective, Self Controlled Clinical Study

This study adopts a multicenter, open, prospective, and self controlled study design, in which each participant serves as their own control before and after receiving amino acid peritoneal dialysis solution treatment to compare changes in their nutritional status. Each subject received treatment with 1 bag of amino acid peritoneal dialysis per day and 2-4 bags of glucose peritoneal dialysis solution per day for 6 months (the amount of glucose peritoneal dialysis solution used was determined based on the treatment plan selected by the patient during the screening period when they entered the study).Before treatment and during the 3rd and 6th months of treatment, subjects were evaluated for various efficacy and safety indicators, and any adverse or serious adverse events were recorded.

Study Overview

• Status: Recruiting
• Conditions: Exploring the Effectiveness and Safety of Amino Acid Peritoneal Dialysis Solution in Improving Nutritional Status of Maintenance Peritoneal Dialysis Patients
• Intervention / Treatment: Drug: Amino acid peritoneal dialysis solution

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Deng shanshan; Phone Number: 8613927596600; Email: 276531255@qq.com

Study Locations

• China
  • Guangdong
    • Gaozhou, Guangdong, China, 525200
      • Recruiting
      • Gaozhou People's Hospital
      • Contact: Deng shanshan; Phone Number: 8613927596600; Email: 276531255@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. For uremic patients with malnutrition during the screening period, maintenance peritoneal dialysis should be performed for at least 3 months. The standard for malnutrition should meet at least two of the following items: (1) serum albumin level<3.5g/dL (35g/L), (2) prealbumin<300mg/L, (3) modifiedSubjective Global Assessment (SGA) with a score of>7;
2. Blood urea nitrogen ≤ 38mmol/L;
3. The patient's age is between 18 and 75 years old;
4. The patient signs an informed consent form.

Exclusion Criteria:

1. Individuals who are allergic to any amino acids or excipients in this product
2. More than one occurrence of peritonitis in the past three months; Peritonitis or hospitalization within the past month;
3. Patients with hyperthyroidism, systemic infection, fever, and other high catabolic metabolic diseases, as well as those who are taking drugs that affect tissue metabolism, such as corticosteroids;
4. Congenital amino acid metabolism deficiency disease, acute severe pancreatitis, severe hyperbilirubinemia 5. Patients with malignant tumor metastasis or spread, residual cancer after treatment, coagulation dysfunction, aplastic anemia, heart, brain, lung and other serious system diseases;

6. Possible kidney transplantation during the trial period; 7. Active phase of hepatitis B or C, liver cirrhosis, active liver disease, liver dysfunction, or positive serum reaction of human immunodeficiency virus (HIV); 8. Those who have participated in clinical trials of other drugs within the three months prior to enrollment; 9. Pregnant and lactating women; 10. Those who are mentally unable to cooperate; 11. Failure to sign a written informed consent form; 12. Unable or unwilling to comply with the experimental protocol approved by the researcher.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Self Control; Compare the nutritional and safety indicators of the subjects before treatment and during the third and sixth months of treatment.	Drug: Amino acid peritoneal dialysis solution; Each subject received treatment with 1 bag of amino acid peritoneal dialysis daily and 2-4 bags of glucose peritoneal dialysis solution daily for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood albumin	Changes in blood albumin levels	Baseline, 3 months, 6 months
prealbumin	Changes in blood prealbumin levels	Baseline, 3 months, 6 months

Collaborators and Investigators

• Sponsor: The People's Hospital of Gaozhou

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2023
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: April 7, 2024
• First Submitted That Met QC Criteria: April 7, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 7, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: amino acid peritoneal dialysis solution；peritoneal dialysis
• Additional Relevant MeSH Terms: Pharmaceutical Solutions; Dialysis Solutions
• Other Study ID Numbers: PHGaozhou

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No